MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS FORTEO 600 MCG/2.4 ML PEN INJ; SYRINGES PISTON

Device Problem Defective Component (2292)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Pain (1994)

Event Type  Injury  

Event Description

Pt states that in the last 2 shipment she has received, she says she received defective needles.She says dr had to add more pressure for needle to go in to dispense medication which caused it to be more painful and left area more red and caused a little bruising some days.She states some needles were ok and difference was that they went in smooth.No other info provided.Pt does not consent to be contacted.

• Brand Name: FORTEO 600 MCG/2.4 ML PEN INJ
• Type of Device: SYRINGES PISTON
• Manufacturer (Section D): ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
• MDR Report Key: 8655308
• MDR Text Key: 146663861
• Report Number: MW5087002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR